CA3122822A1 - Medical assembly including force-limiting device - Google Patents

Abstract

An elongated medical assembly includes a distal section having a distal tip configured to be maneuvered to contact, at least in part, the biological feature of the patient. A force-limiting device is interactable with the distal section. The force-limiting device is configured to limit, at least in part, an amount of a force to be applied from the distal tip of the distal section to the biological feature.

Description

MEDICAL ASSEMBLY INCLUDING FORCE-LIMITING DEVICE
TECHNICAL FIELD
[01] This document relates to the technical field of (and is not limited to) an elongated medical assembly including a force-limiting device (and method therefor).
BACKGROUND

[02] Known medical devices are configured to facilitate a medical procedure and help healthcare providers diagnose and/or treat medical conditions of sick patients.
SUMMARY

[03] It will be appreciated that there exists a need to mitigate (at least in part) at least one problem associated with the existing (known) elongated medical assemblies (also called the existing technology). After much study of, and experimentation with, the existing (known) elongated medical assemblies, an understanding (at least in part) of the problem and its solution have been identified (at least in part) and are articulated (at least in part) as follows:

[04] During known transseptal catheterization procedures, physicians identify the ideal location to cross from the right atrium to the left atrium (of the heart) by first tracking a known medical device into the superior vena cava (of the heart) and then dropping down the known medical device onto the fossa ovalis. In order to do this procedure, the known medical device must have enough reach to make physical contact with the septum (a biological wall) while also contacting the free wall of the right atrium.
These two points of contact (in the right atrium) may be utilized for the application of a tenting force for tenting the fossa ovalis, thereby allowing the physician the ability to cross into the left atrium. Without contacting the septum, crossing into the left atrium cannot occur. Further, insufficient contact with the septum may reduce the certainty and control in the location of the crossing (through the septum), and too much contact with the septum may place excessive force onto the septum, resulting in trauma and/or unintended mechanical puncture of the septum. In order to ensure an ideal amount of reach for the known medical device, the physician must precisely shape the known medical device before the known medical device is inserted into the patient (that is, while the known medical device is positioned outside of the patient); this may not always work out as intended by the physician resulting in removal of the known medical device from the interior of the patient, reshaping the known medical device, reinserting the known medical device and then reattempting the procedure (which is a waste of valuable procedure time and/or may lead to unwanted damage, etc.).
Date Recue/Date Received 2021-06-21

[05] In view of the above issues, it may be desirable to provide a medical device having an adjustment mechanism configured to adjust the reach (preferably this is done automatically) while the medical device is utilized for applying and/or maintaining a contact force onto the septum (or for that matter a force that may be applied to any biological feature that the medical device might make contact with); in this manner, the adjustment mechanism for adjusting the reach (of the distal tip of the medical device) may provide (preferably, but not necessarily) a reduction in the need for the physician to rely on their professional estimation skills to adjust an amount of reach for the distal tip of the medical accessory (while the medical device is moved through the patient toward a target biological feature). In this manner, it may be possible to reduce the application of a contact force from the distal tip of the medical device to the biological wall while the distal tip of the medical device is moved toward the target biological wall of the patient.

[06] During known epicardial access procedures, physicians must pierce the exterior pericardium layer surrounding the heart while avoiding puncture of the underlying myocardium layer (also called the heart muscle tissue). The pericardium layer surrounds the heart similar to a sac. There are sites located on the underlying epicardial surface of the heart (that is, underneath the pericardium layer) that are a target for catheter-based therapies. This requires a delicate access procedure that may be analogous to piercing through a piece of saran wrap covering a steak without damaging the steak itself. To add to the complexity of the procedure, the heart is beating while the physician is attempting to gain access using their instruments. Placing too much force on the exterior surface of the pericardium layer if the heart with an access tool might inadvertently result in unwanted mechanical puncture of the myocardium layer, excessive ischemia to heart muscle tissue, and/or arrhythmias. Too little force applied onto the exterior surface of the pericardium layer might result in difficulties obtaining access and/or a lack of tactile feedback provided back to the physician (via their instruments).

[07] It may be desirable to provide a medical device having a distal tip configured to facilitate contact with a biological feature (such as the heart) and possess a force-control system (such as a dampening system, etc.) configured to ensure that excessive force is not placed on (applied to) the heart from the medical device, as the heart beats and/or as the physician manipulates the medical device for the application of force to the exterior pericardium layer of the heart (or other biological features while the medical device is moved, and positioned, toward a target biological feature).
Date Recue/Date Received 2021-06-21

[08] To mitigate, at least in part, at least one problem associated with the existing technology, there is provided (in accordance with a major aspect) an apparatus. The apparatus is for use with (is configured to use with) a biological feature of a patient. The apparatus includes and is not limited to (comprises) an elongated medical assembly including a distal section having a distal tip configured to be maneuvered to contact, at least in part, the biological feature of the patient. A force-limiting device is positioned proximate to, and is interactable with, the distal section. The force-limiting device is configured to limit, at least in part, an amount of a force to be applied from the distal tip of the distal section to the biological feature after (or once) the distal tip of the distal section, in use, contacts, at least in part, the biological feature of the patient. In accordance with an option, the force-limiting device includes a proximal section positioned proximate to the distal section, and being aligned with the distal section along a common axis extending between the proximal section and the distal section. The proximal section and the distal section are in fluid communication with each other. The force-limiting device is configured to maintain, at least in part, contact with the biological feature of the patient while the distal section is distally movable relative to the proximal section.

[09] To mitigate, at least in part, at least one problem associated with the existing technology, there is provided (in accordance with a major aspect) a method.
The method is for using a distal section having a distal tip of an elongated medical assembly for contacting a biological feature of a patient. The method includes and is not limited to (comprises) maneuvering a distal section having a distal tip of an elongated medical assembly to contact, at least in part, the biological feature of the patient.
The method also includes using a force-limiting device being positioned proximate to, and being interactable with, the distal section, for limiting, at least in part, an amount of a force to be applied from the distal tip of the distal section to the biological feature after (or once) the distal tip of the distal section, in use, contacts, at least in part, the biological feature of the patient.

[010] Other aspects are identified in the claims. Other aspects and features of the non-limiting embodiments may now become apparent to those skilled in the art upon review of the following detailed description of the non-limiting embodiments with the accompanying drawings. This Summary is provided to introduce concepts in simplified form that are further described below in the Detailed Description. This Summary is not intended to identify potentially key features or possible essential features of the disclosed subject matter, and is not intended to describe each disclosed embodiment or every Date Recue/Date Received 2021-06-21 implementation of the disclosed subject matter. Many other novel advantages, features, and relationships will become apparent as this description proceeds. The figures and the description that follow more particularly exemplify illustrative embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS

[011] The non-limiting embodiments may be more fully appreciated by reference to the following detailed description of the non-limiting embodiments when taken in conjunction with the accompanying drawings, in which:

[012] FIG. 1 to FIG. 4 depict side views (FIG. 1 and FIG. 2) and cross-sectional views (FIG. 3 and FIG. 4) of embodiments of an elongated medical assembly; and

[013] FIG. 5 and FIG. 6 depict cross-sectional views of embodiments of the elongated medical assembly of FIG. 1; and

[014] FIG. 7 to FIG. 10 depict cross-sectional views of embodiments of the elongated medical assembly of FIG. 1; and

[015] FIG. 11 to FIG. 13 depict side views of embodiments of the elongated medical assembly of FIG. 1; and

[016] FIG. 14 and FIG. 15 depict side views of embodiments of the elongated medical assembly of FIG. 1; and

[017] FIG. 16 and FIG. 17 depict side views of embodiments of the elongated medical assembly of FIG. 1.

[018] The drawings are not necessarily to scale and may be illustrated by phantom lines, diagrammatic representations and fragmentary views. In certain instances, details unnecessary for an understanding of the embodiments (and/or details that render other details difficult to perceive) may have been omitted. Corresponding reference characters indicate corresponding components throughout the several figures of the drawings.
Elements in the several figures are illustrated for simplicity and clarity and have not been drawn to scale. The dimensions of some of the elements in the figures may be emphasized relative to other elements for facilitating an understanding of the various disclosed embodiments. In addition, common, and well-understood, elements that are useful in commercially feasible embodiments are often not depicted to provide a less obstructed view of the embodiments of the present disclosure.

[019] LISTING OF REFERENCE NUMERALS USED IN THE DRAWINGS
medical assembly 100 Date Recue/Date Received 2021-06-21 movement length 101 applied force 302 distal section 102 biological feature 900 distal lumen 103 patient 902 proximal section 104 heart 903 proximal lumen 105 inferior vena cava 904 distal tip 106 right atrium 906 biasing device 108 superior vena cava 908 wire 109 ascending aorta 910 entrance portal 110 left atrium 912 control-wire lumen 111 descending aorta 914 exit portal 112 interatrial septum 916 leading portion 114 diaphragm 918 common axis 200 liver 920 movement direction 201 diastole condition 922 force-limiting device 300 DETAILED DESCRIPTION OF THE NON-LIMITING EMBODIMENT(S)

[020] The following detailed description is merely exemplary and is not intended to limit the described embodiments or the application and uses of the described embodiments. As used, the word "exemplary" or "illustrative" means "serving as an example, instance, or illustration." Any implementation described as "exemplary" or "illustrative"
is not necessarily to be construed as preferred or advantageous over other implementations. All of the implementations described below are exemplary implementations provided to enable persons skilled in the art to make or use the embodiments of the disclosure and are not intended to limit the scope of the disclosure. The scope of the disclosure is defined by the claims. For the description, the terms "upper," "lower," "left," "rear,"
"right," "front,"
"vertical," "horizontal," and derivatives thereof shall relate to the examples as oriented in the drawings. There is no intention to be bound by any expressed or implied theory in the preceding Technical Field, Background, Summary or the following detailed description. It is also to be understood that the devices and processes illustrated in the attached drawings, and described in the following specification, are exemplary embodiments (examples), aspects and/or concepts defined in the appended claims. Hence, dimensions and other physical characteristics relating to the embodiments disclosed are not to be considered as limiting, unless the claims expressly state otherwise. It is understood that the phrase "at Date Recue/Date Received 2021-06-21 least one" is equivalent to "a". The aspects (examples, alterations, modifications, options, variations, embodiments and any equivalent thereof) are described regarding the drawings.
It should be understood that the disclosure is limited to the subject matter provided by the claims, and that the disclosure is not limited to the particular aspects depicted and described. It will be appreciated that the scope of the meaning of a device configured to be coupled to an item (that is, to be connected to, to interact with the item, etc.) is to be interpreted as the device being configured to be coupled to the item, either directly or indirectly. Therefore, "configured to" may include the meaning "either directly or indirectly" unless specifically stated otherwise.

[021] FIG. 1 to FIG. 4 depict side views (FIG. 1 and FIG. 2) and cross-sectional views (FIG. 3 and FIG. 4) of embodiments of an elongated medical assembly 100. The cross-sectional views of FIG. 3 and FIG. 4 are taken along a cross-sectional line A-A of FIG. 2.

[022] Referring to the embodiments as depicted in FIG. 1 to FIG. 4 (and generally applicable to all of the embodiments), the elongated medical assembly 100 includes a distal section 102 having a distal tip 106 configured to be maneuvered to contact, at least in part, the biological feature 900 of the patient 902. A force-limiting device 300 is positioned proximate to, and is interactable with, the distal section 102. The force-limiting device 300 is configured to limit, at least in part, an amount of a force 302 (contact force) to be applied from the distal tip 106 of the distal section 102 to the biological feature 900 after (or once) the distal tip 106 of the distal section 102 contacts, at least in part, the biological feature 900 of the patient 902. An advantage of an embodiment of the force-limiting device 300 may include adjustment (reduction) of the application of the force 302 from the distal tip 106 to the biological feature 900 while the distal tip 106 of the elongated medical assembly 100 is moved along and toward a targeted biological wall (as depicted in FIG. 11 to FIG. 13). In this manner, an amount of the force 302 applied to other biological features might be kept to a minimum so as to avoid inadvertent damage to these biological features (that might be encountered) while the distal tip 106 of the elongated medical assembly 100 is moved along and toward the targeted biological wall (as depicted in FIG.
11 to FIG. 13). For instance, an embodiment of the elongated medical assembly 100 may be utilized for positioning a puncture device (known and not depicted) for performing a puncturing action for the formation of a puncture site (and/or dilating the puncture site), for the purpose of providing access to the left atrium of the heart during a transseptal catheterization procedure (along with an introducer assembly used for epicardial access procedures, if so desired). The elongated medical assembly 100 is configured to provide a Date Recue/Date Received 2021-06-21 force dampening effect (for instance, when used in the context of epicardial access, and not limited thereto, etc.) when the elongated medical assembly 100 is manipulated by the physician and/or is in contact with a beating heart, etc. In accordance with an option, the force-limiting device includes a proximal section positioned proximate to the distal section, and being aligned with the distal section along a common axis extending between the proximal section and the distal section. The proximal section and the distal section are in fluid communication with each other. The force-limiting device is configured to maintain, at least in part, contact with the biological feature of the patient while the distal section is distally movable relative to the proximal section.

[023] Referring to the embodiments as depicted in FIG. 1 to FIG. 4 (and generally applicable to all of the embodiments), the elongated medical assembly 100 includes biocompatible material properties for desired performance (such as dielectric strength, thermal performance, electrical and/or thermal insulation, corrosion resistance, water resistance, heat resistance, etc.), for safe performance, for compliance with industrial and regulatory safety standards (or compatible for medical usage), etc. Reference is made to the following publication for consideration in the selection of a suitable material: Plastics in Medical Devices: Properties, Requirements, and Applications; 2nd Edition;
author:
Vinny R. Sastri; hardcover ISBN: 9781455732012; published: 21 November 2013;
publisher: Amsterdam [Pay s-B as]: Elsevier! William Andrew, [2014].

[024] Referring to the embodiments as depicted in FIG. 1 to FIG. 4 (and generally applicable to all of the embodiments), preferably, the force-limiting device 300 is configured to limit, at least in part, an amount of a force 302 up to a maximum applicable force to be applied from the distal tip 106 of the distal section 102 to the biological feature 900 after (or once) the distal tip 106 of the distal section 102 contacts, at least in part, the biological feature 900 of the patient 902.

[025] Referring to the embodiments as depicted in FIG. 1 to FIG. 4 (and generally applicable to all of the embodiments), there is provided a method for using the distal section 102 having the distal tip 106 of the elongated medical assembly 100 for contacting the biological feature 900 of the patient 902. The method includes maneuvering the distal tip 106 of the distal section 102 of the elongated medical assembly 100 to contact, at least in part, the biological feature 900 of the patient 902. The method also includes using a force-limiting device 300 (that is positioned proximate to, and is interactable with, the distal section 102) for limiting, at least in part, an amount of a force 302 to be applied from the distal tip 106 of the distal section 102 to the biological feature 900;
this is done, Date Recue/Date Received 2021-06-21 preferably, after (or once) the distal tip 106 of the distal section 102 contacts, at least in part, the biological feature 900 of the patient 902.

[026] Referring to the embodiments as depicted in FIG. 1 to FIG. 4, the force-limiting device 300 includes a synergistic combination of a proximal section 104 and a biasing device 108. The proximal section 104 is positioned proximate to the distal section 102.
The proximal section 104 is (coaxially) aligned with the distal section 102 along a common axis 200 extending between the proximal section 104 and the distal section 102.
The proximal section 104 and the distal section 102 are in fluid communication (internal fluid communication) with each other. The biasing device 108 is positioned between the proximal section 104 and the distal section 102. The biasing device 108 may include a spring element, a bias spring structure, a mechanical bias, etc., and any equivalent thereof.
The biasing device 108 is attached to the proximal section 104 and the distal section 102.

[027] Referring to the embodiments as depicted in FIG. 1 and FIG. 2, the force-limiting device 300 is configured (preferably) to dynamically adjust (automatically adjust) the reach of the distal tip 106 of the distal section 102 (for the case where the biasing device 108 is deployed) so that the distal section 102 is able to slide over a section of the proximal section 104, depending on the possible biological features that might be encountered or contacted while the surgeon inserts and moves the distal section 102 (of the elongated medical assembly 100) through the body of the patient 902 (as depicted in FIG.
11 to FIG.
13) toward a targeted biological feature. The biasing device 108 is configured to maintain (at least in part) the contact force within a defined window as the user (physician) tracks (moves) the distal section 102 (of elongated medical assembly 100) through the patient.
The distal section 102 may be moved (at least in part) along the proximal section 104; this arrangement helps to maintain the contact force with the biological feature (such as the septum of the heart) by, preferably, dynamically adjusting an amount of reach (of the distal section 102) as (A) the distal section 102 interacts with (contacts) various biological tissues and/or (B) changes to the relative applied forces resulting in inadvertent (unwanted) contact with various biological tissues (while the distal section 102 is moved toward the targeted biological feature). The distal section 102 is moved (actuated) via the biasing device 108. In doing so, the application of excessive force to the biological feature (such as the heart) via the distal tip 106 may be reduced and/or (preferably) avoided.

[028] Referring to the embodiments as depicted in FIG. 1 and FIG. 2, the biasing device 108 joins (attaches) the distal section 102 and the proximal section 104 with each other.
The biasing device 108 is configured to control (specifically, automatically control) the Date Recue/Date Received 2021-06-21 relative displacement between the distal section 102 and the proximal section 104. The biasing device 108 controls the force window within which the distal section 102 might be moved (actuate within). The biasing device 108 may provide any equivalent of a spring constant (such as a spring connecting the distal section 102 and the proximal section 104).
The spring constant is preferably about 0.25 Newtons per millimeter. It will be appreciated that any spring constant may be used for the biasing device 108 that is attached (affixed) to the distal section 102 and the proximal section 104. The biasing device 108 is configured to allow displacement of the distal section 102 relative to the proximal section 104 when the distal tip 106 encounters biological tissue (such as the interatrial septum, the exterior of heart, the pericardium layer, etc.) and experiences forces that might be encountered during a procedure (such as a transseptal/epicardial access procedure). The biasing device 108 is, preferably, not so stiff as to cause inadvertent damage to tissue while facilitating actuation (movement) of the distal section 102, and/or is not so compliant as to easily bottom out against the proximal section 104 during a typical procedure.

[029] Referring to the embodiments as depicted in FIG. 1 to FIG. 4 (and generally applicable to all of the embodiments), the distal section 102 has the distal tip 106 configured to be maneuvered within, at least in part, the patient 902, and to be positioned proximate to (and, preferably, for contact with) the biological feature 900 of the patient 902. The distal section 102 and the distal tip 106 are configured to be maneuvered within and along the patient 902. The proximal section 104 is positioned proximate to, and is movable relative to, the distal section 102. The proximal section 104 is (coaxially) aligned with the distal section 102 along a common axis 200 extending between the proximal section 104 and the distal section 102. The proximal section 104 is, preferably, coaxially aligned with the distal section 102. The proximal section 104 and the distal section 102 are in fluid communication with each other. The proximal section 104 and the distal section 102 are independently movable, at least in part, relative to each along a movement length 101. The proximal section 104 and the distal section 102 remain in fluid communication with each other while the proximal section 104 and the distal section 102 are independently movable, at least in part, relative to each along the movement length 101.

[030] Referring to the embodiments as depicted in FIG. 1 to FIG. 4 (and generally applicable to all of the embodiments), the distal section 102 defines (preferably) a distal lumen 103. The proximal section 104 defines (preferably) a proximal lumen 105.
The distal lumen 103 of the distal section 102 and the proximal lumen 105 of the proximal Date Recue/Date Received 2021-06-21 section 104 are in fluid communication with each other (after the proximal section 104 is positioned proximate to the distal section 102).

[031] Referring to the embodiments as depicted in FIG. 1 and FIG. 2, the distal section 102 defines an entrance portal 110. The distal section 102 defines an exit portal 112. The exit portal 112 is spaced apart from the entrance portal 110. The proximal section 104 includes a leading portion 114. The leading portion 114 (of the proximal section 104) is configured to be received (at least in part) within the entrance portal 110 of the distal section 102 (leading into an interior cavity of the distal section 102). Once the leading portion 114 (of the proximal section 104) is received (at least in part) within the entrance portal 110, the leading portion 114 remains within the interior of the distal section 102 (by devices known and not depicted). In this manner, the distal section 102 interfaces with the proximal section 104. The distal section 102 (preferably) travels over (overlaps), at least in part, the proximal section 104. The distal section 102 is configured to be movable along the movement direction 201. The distal section 102 is configured to telescopically extend from the proximal section 104.

[032] Referring to the embodiments as depicted in FIG. 1 and FIG. 2, the distal section 102 (distal shaft) and the proximal section 104 (proximal shaft) are constructed in a manner that allows them to displace relative to each other (preferably, for a predetermined distance or length). The distal section 102 and the proximal section 104 are configured to be movable relative to each other, at least for over the movement length 101 (also called a coaxial movement length or an overlap length, etc.). The outer diameter of the distal section 102 is, preferably, from about 8.0 French to about 12.0 French. It will be appreciated that any outer diameter of the distal section 102 may be used.
Preferably, the outer diameter of the distal section 102 is able to fit within the patient anatomy and allow relative movement with the proximal section 104. The inner diameter of the distal section 102 is, preferably, about at least 0.927 millimeters. It will be appreciated that any inner diameter of the distal section 102 may be used. Preferably, the inner diameter of the distal section 102 has a size that allows conventional transseptal/epicardial devices (guidewires, needles, etc.) to be passed through. It will be appreciated that any length of the proximal section 104 may be used. Preferably, the length of the proximal section 104 may reach the desired (targeted) patient anatomy from a chosen access site and facilitate sufficient relative displacement to the proximal section 104. The length of the distal section 102 is, preferably, about 4.0 centimeters. The material of the distal section 102 may include high-density polyethylene (HDPE) or any equivalent thereof. It will be appreciated that any Date Recue/Date Received 2021-06-21 biocompatible material can be used for the material of the distal section 102.
Preferably, the material has sufficient stiffness for use in the selected procedure. The distal section 102 may have a maximum displacement (over the proximal section 104 or overlaps, at least in part, with the proximal section 104) of about 2.0 centimeters. It will be appreciated that any maximum displacement of the distal section 102 may utilized. Preferably, the total displacement of the distal section 102 may travel relative to the proximal section 104 to facilitate shock absorption (preferably through the steps in the procedure).
Preferably, the distal section 102 does not bottom out against the proximal section 104 during the procedure.

[033] Referring to the embodiments as depicted in FIG. 1 and FIG. 2, for epicardial access, the distal tip 106 is relatively soft and/or compliant, and may help to reduce inadvertent trauma caused by excessive force input. Steerable sheaths and dilators can help with positioning a transseptal access device against the septum; however, a telescopic distal section may further enable precise tenting with the distal tip 106 against a desired biological feature or location. The outer diameter of the distal tip 106 is, preferably, about 1.4 millimeters. It will be appreciated that any outer diameter of the distal tip 106 may be used. Preferably, the outer dimeter of the distal tip 106 facilitates desired performance during transseptal/epicardial access procedures. The inner diameter of the distal tip 106 ranges, preferably, from about 0.927 millimeters to about 0.953 millimeters.
It will be appreciated that any inner diameter of the distal tip 106 may be used provided the inner diameter of the distal tip 106 facilitates desired performance during transseptal/epicardial access procedures. Preferably, the inner diameter of the distal tip 106 has a size that allows conventional transseptal/epicardial devices (guidewires, needles, etc.) to be passed through. The distal curve angle of the distal tip 106 may range from about 0.0 degrees to about 66 degrees. It will be appreciated that the curvature applied to the distal tip 106 may be dependent on the chosen procedure. Transseptal devices typically have a curvature angle between about 45 degrees and about 66 degrees associated with them so that they are able to angle towards and point in the direction of the interatrial septum. On the other hand, epicardial access tools do not have any kind of distal curve angle associated with them. Alternatively, a steerable feature (known and not depicted) may be employed where the distal curvature may be changed (preferably dynamically) by the user.
Overall, the distal curvature of the device should facilitate the chosen procedure.

[034] Referring to the embodiments as depicted in FIG. 1 and FIG. 2, the proximal section 104 may include any hub compatible device (positioned at the proximal section) having a Date Recue/Date Received 2021-06-21 luer lock fitting and/or slip tip syringes, etc. A hub is not strictly required for proper functioning of the elongated medical assembly 100. Hubs make the elongated medical assembly 100 easier to use. Preferably, the elongated medical assembly 100 is compatible with conventional accessory devices such as syringes. The outer diameter of the proximal section 104 is, preferably, from about 5.0 French to about 8.5 French. It will be appreciated that any outer diameter of the proximal section 104 may be used.
Preferably, the proximal section 104 may fit within the patient anatomy and allow relative movement with the distal section 102. The inner diameter of the proximal section 104 is, preferably, from about 0.927 millimeters to about 1.83 millimeters. It will be appreciated that any inner diameter of the proximal section 104 may be used. Preferably, the inner diameter of the proximal section 104 has a size that allows conventional transseptal/epicardial devices (guidewires, needles, etc.) to be passed through. The length of the proximal section 104 is, preferably, from about 10 to about 95 centimeters. It will be appreciated that any length of the proximal section 104 may be used. Preferably, the length of the proximal section 104 may reach the desired patient anatomy from a chosen access site. The material of the proximal section 104 may include high-density polyethylene (HDPE) or any equivalent thereof. It will be appreciated that any biocompatible material can be used for the proximal section 104. Preferably, the material has sufficient stiffness for use in the selected procedure.

[035] Referring to the embodiments as depicted in FIG. 3, and FIG. 4, the biasing device 108 is configured to urge (normally urge) the distal section 102 to move to a fully extended position away from the proximal section 104. The biasing device 108 may include an internal spring, and any equivalent thereof. The biasing device 108 is configured to be compressed thereby shortening the overall length of the distal section 102 and the proximal section 104 (in response to the distal tip 106 making contact with a biological feature 900, a biological wall or tissue, etc.). Contact between the distal tip 106 of the distal section 102 and the biological feature 900 is depicted in FIG.
4. Cooperative action between the distal section 102 and the proximal section 104 avoids, at least in part, application of excessive force to the biological feature 900 as the distal tip 106 of the distal section 102 is moved toward and/or through the biological feature 900 (such as the heart).
The distal section 102 and the proximal section 104 may be constructed to accommodate the largest patient anatomy that may be expected. The distal section 102 may be moved to shorten the overall length of the combination of the distal section 102 and the proximal section 104 via compression of the biasing device 108; this arrangement may ensure that Date Recue/Date Received 2021-06-21 enough reach may be maintained with the biological feature 900 or patient anatomies, etc.).

[036] Referring to the embodiment as depicted in FIG. 4, the distal section 102 is fully compressed against or toward the proximal section 104. An input force resulting from any interaction with the biological feature 900 at the distal tip 106 may cause the distal section 102 to move (back and forth) as the biasing device 108 may serve to dampen potential shocks imparted to the biological feature 900 from the distal tip 106.

[037] FIG. 5 and FIG. 6 depict cross-sectional views of embodiments of the elongated medical assembly 100 of FIG. 1

[038] Referring to the embodiments as depicted in FIG. 5 and FIG. 6, the force-limiting device 300 includes the proximal section 104 positioned proximate to the distal section 102. The proximal section 104 is aligned (preferably coaxially aligned) with the distal section 102 along a common axis 200 extending between the proximal section 104 and the distal section 102. The proximal section 104 and the distal section 102 are in fluid communication with each other. A control wire 109 extends to the distal section 102 (and is attached to the distal section 102). The proximal section 104 defines a control-wire lumen 111 configured to receive the control wire 109. The control wire 109 is configured to provide user control for the distal section 102. The proximal section 104 and the distal section 102 are user controllable for independent relative movement between the proximal section 104 and the distal section 102.

[039] Referring to the embodiment as depicted in FIG. 5, it will be appreciated that the biasing device 108 is utilized for causing relative movement between the distal section 102 and the proximal section 104. The distal section 102 is configured to be manually controlled by the user, thereby allowing for varying levels of protrusion of the distal section 102 relative to the proximal section 104 (if desired). The user may be able to telescope the distal section 102 out further from the proximal section 104 if greater reach (of the distal section 102) is needed when trying to tent the biological wall (such as the interatrial septum) with the distal tip 106. It will be appreciated that a locking feature (known and not depicted) may be added, which gives the user the ability to lock the position of the distal section 102 relative to the proximal section 104, thereby no longer allowing relative movement between the distal section 102 and the proximal section 104.

[040] Referring to the embodiment as depicted in FIG. 6, it will be appreciated that the control wire 109 may be positioned outside of the proximal section 104.
Date Recue/Date Received 2021-06-21

[041] Referring to the embodiment as depicted in FIG. 5, the distal tip 106 of the distal section 102 and the proximal section 104 are protracted (moved together in unison, more or less by the user) toward the biological feature 900 so that eventually the distal tip 106 may make contact (in a nice and easy or gentle manner) with the biological feature 900.
The proximal section 104 is moved in response to the user moving the proximate end section (not depicted) of the proximal section 104 that sticks out from the patient. The distal tip 106 of the distal section 102 are moved in response to the user moving the control wire 109 (the control wire 109 extends from the proximate end section (not depicted) of the proximal section 104 that sticks out from the patient).

[042] Referring to the embodiment as depicted in FIG. 6, the distal tip 106 of the distal section 102 and the proximal section 104 are continued to be protracted (moved together in unison) toward the biological feature 900; in this manner, the distal tip 106 eventually makes contact with the biological feature 900 (preferably in a gentle manner that avoids imparting unwanted damage to the biological feature 900). After contact is made between the distal tip 106 and the biological feature 900, the user should feel the resistance to movement of the distal section 102 (via the control wire 109) while the resistance to movement of the proximal section 104 is felt much less, so that the proximal section 104 may continue to move freely toward the biological feature 900; in this case, the user may cognitively understand that the distal tip 106 has made an initial contact with the biological feature 900 (preferably without inadvertently striking the biological feature 900 with a damaging force). A nice and easy movement of the distal section 102 is preferred for avoiding unwanted damage to the biological feature 900. The user may ponder and consider whether to back off and move the distal tip 106 of the distal section 102 (by moving the control wire 109) away from the biological feature 900 (if so desired, such as when the user determines that the biological feature 900 is determined not to be the desired or targeted biological feature (this determination may be done by referring to the display device of a medical imaging system, known and not depicted). For instance, this condition might be desired when the user makes a determination that the biological feature 900 is not the desired biological feature (that should receive a tenting force), and that it may be necessary to continue moving the distal section 102 to another location (preferably, to position the distal section 102 proximate to a desired biological feature, for instance).
However, for the case where the user makes a positive determination that the biological feature 900 is, in fact, the desired biological feature (that should receive a tenting force), then the user may apply the tenting force (such as the force 302) to the biological feature Date Recue/Date Received 2021-06-21 900. Application of the tenting force might be accomplished by moving the proximal section 104 toward the distal section 102 so that the proximal section 104 and the distal section 102 make contact with each other, and the tenting force may then be transferred from the user to the distal section 102 via the proximal section 104.

[043] FIG. 7 to FIG. 10 depict cross-sectional views of embodiments of the elongated medical assembly 100 of FIG. 1.

[044] Referring to the embodiments as depicted in FIG. 7 to FIG. 10, the force-limiting device 300 includes the proximal section 104 positioned proximate to the distal section 102. The proximal section 104 is aligned (preferably, coaxially aligned) with the distal section 102 along a common axis 200 extending between the proximal section 104 and the distal section 102. The proximal section 104 and the distal section 102 are in fluid communication (internal fluid communication) with each other. The proximal section 104 and the distal section 102 are user controllable for independent relative movement between the proximal section 104 and the distal section 102.

[045] Referring to the embodiment as depicted in FIG. 7, the distal section 102 includes a distal-proximate end section configured to extend from the patient after the distal section 102 is inserted into the patient. The distal section 102 is movable in response to a user urging movement of (that is, an urging movement imparted to) the distal-proximate end section of the distal section 102. The proximal section 104 includes a proximal-proximate end section configured to extend from the patient after the proximal section 104 is inserted into the patient. The proximal section 104 is movable in response to the user urging movement of (that is, an urging movement imparted to) the proximal-proximate end section of the proximal section 104.

[046] Referring to the embodiment as depicted in FIG. 7, the distal tip 106 of the distal section 102 and the proximal section 104 are protracted (moved together in unison, more or less by the user from the proximate end sections (not depicted) of the distal section 102 and the proximal section 104 that stick out from the patient) toward the biological feature 900 so that eventually the distal tip 106 may make contact (in a nice and easy or gentle manner) with the biological feature 900.

[047] Referring to the embodiment as depicted in FIG. 8, the distal tip 106 of the distal section 102 and the proximal section 104 continue to be protracted (moved together in unison) toward the biological feature 900 so that the distal tip 106 eventually makes contact with the biological feature 900 (preferably, in a gentle manner that avoids imparting unwanted damage to the biological feature 900). After contact is made between Date Recue/Date Received 2021-06-21 the distal tip 106 and the biological feature 900, the user should feel the resistance to movement of the distal section 102 while the resistance to movement of the proximal section 104 is felt much less, so that the proximal section 104 may continue to move freely toward the biological feature 900; in this case, the user may cognitively understand that the distal tip 106 has made an initial contact with the biological feature 900 (preferably without inadvertently striking the biological feature 900 with a damaging force). A nice and easy movement of the distal section 102 is preferred for avoiding unwanted damage to the biological feature 900. The user may ponder and consider whether to back off and move the distal tip 106 of the distal section 102 away from the biological feature 900 (if so desired, such as when the user determines that the biological feature 900 of FIG. 8 is determined not to be the (desired) targeted biological feature (this may be determined with assistance from a display device of a medical imaging system, known and not depicted).
For instance, this condition might be desired when the user makes a determination that the biological feature 900 is not the desired biological feature (that should receive a tenting force), and that it may be necessary to continue moving the distal section 102 to another location (preferably to position the distal section 102 may be positioned proximate to a desired biological feature as for the case depicted in FIG. 9, for instance).

[048] Referring to the embodiment as depicted in FIG. 9, the user has determined that it is necessary to continue movement of the distal tip 106 of the distal section 102 toward another target, such as the biological feature 900, as depicted in FIG. 9 (on the basis that the biological feature 900 of FIG. 9 is a target biological feature that needs to receive a tenting force, or other treatment, etc.). The distal tip 106 of the distal section 102 is protracted (moved) toward the biological feature 900, and the biological feature 900 becomes tented (due to the application of the force 302 from the distal tip 106 to the biological feature 900); this is done while the proximal section 104 remains relatively unmoved (relative to the movement of the distal tip 106). As a result of this relative movement, the leading portion 114 of the proximal section 104 becomes positioned away from the distal tip 106 after (once) the distal section 102 is protracted (moved) toward the biological feature 900.

[049] Referring to the embodiment as depicted in FIG. 10, application of the tenting force (as depicted in FIG. 9) is no longer required or the medical procedure is completed, etc.
and the distal tip 106 of the distal section 102 is retracted (moved) away from the biological feature 900, and the biological feature 900 becomes relaxed (due to less or no force applied from the distal tip 106 to the biological feature 900). As a result, the leading Date Recue/Date Received 2021-06-21 portion 114 of the proximal section 104 becomes positioned closer to the distal tip 106 after (once) the distal section 102 is retracted (moved) away from the biological feature 900.

[050] FIG. 11 to FIG. 13 depict side views of embodiments of the elongated medical assembly 100 of FIG. 1, in which there are depicted embodiments of a transseptal workflow.

[051] Referring to the embodiment as depicted in FIG. 10, the distal section 102 and the proximal section 104 are initially placed (positioned) in the superior vena cava 908 of the heart 903. Other features of the heart 903 are also depicted, such as the inferior vena cava 904, the right atrium 906, the ascending aorta 910, the left atrium 912 and the descending aorta 914. The distal section 102 is moved relative to (or over) the proximal section 104 as the distal tip 106 (of the distal section 102) is pressed against tissue.
Cooperative action between the distal section 102 and the proximal section 104 helps to mitigate inadvertent trauma to tissue while maintaining (at least in part) contact between the distal section 102 and the biological tissue (the biological feature 900); this may be performed, preferably, automatically where the biasing device 108 is deployed (as depicted in FIG.
3).

[052] Referring to the embodiment as depicted in FIG. 11, the distal section 102 and the proximal section 104 are brought down from the superior vena cava 908 to drop onto the fossa ovalis (the interatrial septum 916). As the distal section 102 and the proximal section 104 are removed from tighter vasculature, the distal section 102 is able to move relative to (such as telescope further out from) the proximal section 104 while the distal section 102 maintains, advantageously, in contact with the tissue; this may be performed automatically for cases where the biasing device 108 is deployed (as depicted in FIG. 3).

[053] Referring to the embodiment as depicted in FIG. 12, the distal section 102 is moved to tent against the fossa ovalis (the interatrial septum 916). The distal section 102 is moved relative to (such as, back and forth over) the proximal section 104 as the user (not depicted) manipulates the proximal section 104 while the heart 903 beats.
Cooperative action between the distal section 102 and the proximal section 104 maintains tissue contact between the interatrial septum 916 and the distal tip 106 (of the distal section 102) also absorbs (to some extent) shock (forces), and may also help to mitigate inadvertent tissue trauma and/or unintentional mechanical crossing of the interatrial septum 916;
this may be performed automatically (in accordance with a preferred embodiment) for the case where the biasing device 108 is deployed (as depicted in FIG. 3).
Date Recue/Date Received 2021-06-21

[054] FIG. 14 and FIG. 15 depict side views of embodiments of the elongated medical assembly 100 of FIG. 1.

[055] Referring to the embodiments as depicted in FIG. 14 and FIG. 15, the distal tip 106 of the distal section 102 is moved (along the movement direction 201); this is done in such a way that the distal tip 106 (of the distal section 102) tents against the interatrial septum 916 (fossa ovalis) of the heart 903 (that is, the biological feature 900). As the heart 903 beats, the distal section 102 is configured to move relative to (that is, move over) the proximal section 104 to maintain tissue contact; this may be performed automatically for the case where the biasing device 108 is deployed (as depicted in FIG. 3).

[056] Referring to the embodiment as depicted in FIG. 14, the interatrial septum 916 is shown moving further away from the distal tip 106, but the distal section 102 is able to move relative to (that is, telescope over, along the movement direction 201) the proximal section 104 so that the distal tip 106 may maintain contact with the interatrial septum 916.

[057] Referring to the embodiment as depicted in FIG. 15, the interatrial septum 916 is depicted moving closer to the distal tip 106 of the distal section 102 (the dashed lines depict the position of the interatrial septum 916 from the position as depicted in FIG. 14).
To avoid placement of excessive mechanical force onto the interatrial septum 916 by the distal section 102, the distal section 102 is configured to move (preferably, automatically) relative to (that is, over) the proximal section 104 (along the movement direction 201); this may be performed automatically for the case where the biasing device 108 is deployed (as depicted in FIG. 3). In this manner, the distal section 102 and the proximal section 104 cooperate to dampen the force to be applied to the interatrial septum 916.

[058] FIG. 16 and FIG. 17 depict side views of embodiments of the elongated medical assembly 100 of FIG. 1.

[059] Referring to the embodiments as depicted in FIG. 15 and FIG. 16, the medical assembly 100 is utilized in an epicardial access procedure.

[060] Referring to the embodiment as depicted in FIG. 15, the heart 903 is depicted in the start (beginning) of the diastole phase (or the end of the systole phase) when the ventricles are empty. The diastole phase of the heartbeat occurs when the heart muscle relaxes and allows the chambers of the heart to receive (to fill with) blood. The distal tip 106 (of the distal section 102) is docked against the heart 903 (as the heart 903 beats).
In the end of the systole phase, the heart 903 retracts away from the distal tip 106. To maintain contact with beating of the heart 903, the distal section 102 moves (telescopes over) relative to the proximal section 104; this is done in such a way that the distal section 102 advances Date Recue/Date Received 2021-06-21 forwardly (along the movement direction 201); this may be performed automatically for the case where the biasing device 108 is deployed (as depicted in FIG. 3).

[061] Referring to the embodiment as depicted in FIG. 16, the heart 903 is shown at the start of the systole phase (or the end of the diastole phase) when the ventricles (of the heart 903) are filled with blood and the heart 903 advances towards the distal tip 106. The systole phase occurs when the heart muscle contracts to pump blood out from the interior of the heart. To prevent excessive mechanical force on the heart 903 via the distal section 102, the distal section 102 is configured to retract (preferably, automatically) over the proximal section 104 along the movement direction 201; this may be performed automatically for the case where the biasing device 108 is deployed (as depicted in FIG.
3).

[062] The following is offered as further description of the embodiments, in which any one or more of any technical feature (described in the detailed description, the summary and the claims) may be combinable with any other one or more of any technical feature (described in the detailed description, the summary and the claims). It is understood that each claim in the claims section is an open-ended claim unless stated otherwise. Unless otherwise specified, relational terms used in these specifications should be construed to include certain tolerances that the person skilled in the art would recognize as providing equivalent functionality. By way of example, the term perpendicular is not necessarily limited to 90.0 degrees and may include a variation thereof that the person skilled in the art would recognize as providing equivalent functionality for the purposes described for the relevant member or element. Terms such as "about" and "substantially", in the context of configuration, relate generally to disposition, location, or configuration that are either exact or sufficiently close to the location, disposition, or configuration of the relevant element to preserve operability of the element within the disclosure which does not materially modify the disclosure. Similarly, unless specifically made clear from its context, numerical values should be construed to include certain tolerances that the person skilled in the art would recognize as having negligible importance as they do not materially change the operability of the disclosure. It will be appreciated that the description and/or drawings identify and describe embodiments of the apparatus (either explicitly or inherently). The apparatus may include any suitable combination and/or permutation of the technical features as identified in the detailed description, as may be required and/or desired to suit a particular technical purpose and/or technical function. It will be appreciated that, where possible and suitable, any one or more of the technical features of Date Recue/Date Received 2021-06-21 the apparatus may be combined with any other one or more of the technical features of the apparatus (in any combination and/or permutation). It will be appreciated that persons skilled in the art would know that the technical features of each embodiment may be deployed (where possible) in other embodiments even if not expressly stated as such above. It will be appreciated that persons skilled in the art would know that other options may be possible for the configuration of the components of the apparatus to adjust to manufacturing requirements and still remain within the scope as described in at least one or more of the claims. This written description provides embodiments, including the best mode, and also enables the person skilled in the art to make and use the embodiments. The patentable scope may be defined by the claims. The written description and/or drawings may help to understand the scope of the claims. It is believed that all the crucial aspects of the disclosed subject matter have been provided in this document. It is understood, for this document, that the word "includes" is equivalent to the word "comprising" in that both words are used to signify an open-ended listing of assemblies, components, parts, etc. The term "comprising", which is synonymous with the terms "including,"
"containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. Comprising (comprised of) is an "open" phrase and allows coverage of technologies that employ additional, unrecited elements. When used in a claim, the word "comprising" is the transitory verb (transitional term) that separates the preamble of the claim from the technical features of the disclosure. The foregoing has outlined the non-limiting embodiments (examples). The description is made for particular non-limiting embodiments (examples). It is understood that the non-limiting embodiments are merely illustrative as examples.
Date Recue/Date Received 2021-06-21

Claims (21)

CLAMS
WHAT IS CLAMED IS:

1. An apparatus for use with a biological feature of a patient, the apparatus comprising:
an elongated medical assembly, including:
a distal section having a distal tip configured to be maneuvered to contact, at least in part, the biological feature of the patient; and a force-limiting device being positioned proximate to, and being interactable with, the distal section.

2. The apparatus of claim 1, wherein:
the force-limiting device is configured to limit, at least in part, an amount of a force to be applied from the distal tip of the distal section to the biological feature after the distal tip of the distal section, in use, contacts, at least in part, the biological feature of the patient.

3. The apparatus of claim 1, wherein:
the force-limiting device includes:
a proximal section being positioned proximate to the distal section, and being aligned with the distal section along a common axis extending between the proximal section and the distal section; and wherein the proximal section and the distal section are in fluid communication with each other; and wherein the force-limiting device is configured to maintain, at least in part, contact with the biological feature of the patient while the distal section is distally movable relative to the proximal section.

4. The apparatus of claim 1, wherein:
the force-limiting device is configured to limit, at least in part, an amount of a force up to a maximum applicable force to be applied from the distal tip of the distal section to the biological feature after the distal tip of the distal section, in use, contacts, at least in part, the biological feature of the patient.

5. The apparatus of claim 1, wherein:
the force-limiting device includes:
Date Recue/Date Received 202 1-06-2 1 a proximal section being positioned proximate to the distal section, and aligned with the distal section along a common axis extending between the proximal section and the distal section; and the proximal section and the distal section being in fluid communication with each other; and a biasing device attached to the proximal section and the distal section.

6. The apparatus of claim 1, wherein:
the force-limiting device includes:
a proximal section being positioned proximate to the distal section, and aligned with the distal section along a common axis extending between the proximal section and the distal section; and the proximal section and the distal section being in fluid communication with each other; and a control wire extending to the distal section, and being attached to the distal section.

7. The apparatus of claim 6, wherein:
the control wire is configured to provide user control for the distal section; and the proximal section is user controllable for independent relative movement between the proximal section and the distal section.

8. The apparatus of claim 6, wherein:
the proximal section defines a control-wire lumen configured to receive the control wire.

9. The apparatus of claim 1, wherein:
the force-limiting device includes:
a proximal section being positioned proximate to the distal section, and aligned with the distal section along a common axis extending between the proximal section and the distal section.

10. The apparatus of claim 9, wherein:
the proximal section and the distal section being in fluid communication with each other; and Date Recue/Date Received 202 1-06-2 1 the proximal section and the distal section are user controllable for independent relative movement between the proximal section and the distal section.

11. The apparatus of claim 9, wherein:
the proximal section includes a proximal-proximate end section configured to extend from the patient after the proximal section is inserted into the patient.

12. The apparatus of claim 9, wherein:
the distal section includes a distal-proximate end section configured to extend from the patient after the distal section is inserted into the patient.

13. The apparatus of claim 12, wherein:
the distal section is movable in response to an urging movement imparted to the distal-proximate end section of the distal section.

14. The apparatus of claim 11, wherein:
the proximal section is movable in response to an urging movement imparted to the proximal-proximate end section of the proximal section.

15. A method is for using a distal section having a distal tip of an elongated medical assembly for contacting a biological feature of a patient, the method comprising:
maneuvering the distal tip of the distal section of the elongated medical assembly to contact, at least in part, the biological feature of the patient; and using a force-limiting device being positioned proximate to, and being interactable with, the distal section, for limiting, at least in part, an amount of a force to be applied from the distal tip of the distal section to the biological feature after the distal tip of the distal section, in use, contacts, at least in part, the biological feature of the patient.

16. The method of claim 15, further comprising:
limiting, at least in part, an amount of a force to be applied from the distal tip of the distal section to the biological feature after the distal tip of the distal section, in use, contacts, at least in part, the biological feature of the patient.

17. The method of claim 15, further comprising:
Date Recue/Date Received 202 1-06-2 1 maintaining, at least in part, contact with the biological feature of the patient while the distal section is distally movable relative to a proximal section of the force-limiting device, in which the proximal section is positioned proximate to the distal section, and is aligned with the distal section along a common axis extending between the proximal section and the distal section, and the proximal section and the distal section are in fluid communication with each other.

18. The method of claim 15, further comprising:
limiting, at least in part, an amount of a force up to a maximum applicable force to be applied from the distal tip of the distal section to the biological feature after the distal tip of the distal section, in use, contacts, at least in part, the biological feature of the patient.

19. The method of claim 15, wherein:
the force-limiting device includes:
a proximal section being positioned proximate to the distal section, and aligned with the distal section along a common axis extending between the proximal section and the distal section; and the proximal section and the distal section being in fluid communication with each other; and a biasing device attached to the proximal section and the distal section.

20. The method of claim 15, wherein:
the force-limiting device includes:
a proximal section being positioned proximate to the distal section, and aligned with the distal section along a common axis extending between the proximal section and the distal section; and the proximal section and the distal section being in fluid communication with each other; and a control wire extending to the distal section, and being attached to the distal section; and the control wire is configured to provide user control for the distal section; and the proximal section is user controllable for independent relative movement between the proximal section and the distal section.
Date Recue/Date Received 202 1-06-2 1

21. The method of claim 15, wherein:
the force-limiting device includes:
a proximal section being positioned proximate to the distal section, and aligned with the distal section along a common axis extending between the proximal section and the distal section.
the proximal section and the distal section being in fluid communication with each other; and the proximal section and the distal section are user controllable for independent relative movement between the proximal section and the distal section.
Date Recue/Date Received 202 1-06-2 1